UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059279 |
|---|---|
| Receipt number | R000067809 |
| Scientific Title | A Multicenter Prospective Observational Study on the Efficacy of Intracapsular Tonsillectomy for Pediatric Obstructive Sleep Apnea |
| Date of disclosure of the study information | 2025/10/10 |
| Last modified on | 2025/10/03 16:13:26 |
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Basic information
Public title
A Multicenter Prospective Observational Study on the Efficacy of Intracapsular Tonsillectomy for Pediatric Obstructive Sleep Apnea
Acronym
A Multicenter Prospective Observational Study on the Efficacy of Intracapsular Tonsillectomy for Pediatric Obstructive Sleep Apnea
Scientific Title
A Multicenter Prospective Observational Study on the Efficacy of Intracapsular Tonsillectomy for Pediatric Obstructive Sleep Apnea
Scientific Title:Acronym
A Multicenter Prospective Observational Study on the Efficacy of Intracapsular Tonsillectomy for Pediatric Obstructive Sleep Apnea
Region
| Japan |
Condition
Condition
Pediatric Obstructive Sleep Apnea
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we aim to compare intracapsular tonsillectomy with Coblator (CIT), intracapsular tonsillectomy with microdebrider (PIT), and conventional extracapsular tonsillectomy for pediatric obstructive sleep apnea (OSA),with the following objectives;
1.Comparison of Postoperative Pain
We will compare pain scores from the day after surgery through postoperative day 5 across surgical techniques to evaluate the degree of pain reduction. Additionally, the amount of analgesic use will be assessed to examine postoperative recovery.
2.Verification of Safety
We will record adverse events such as postoperative hemorrhage and tissue damage to evaluate differences in safety between procedures.
3.Assessment of Surgical Factors
We will investigate whether differences in surgical time or the surgeon's years of experience influence the outcomes depending on the surgical method.
4.Evaluation of Postoperative Course
After discharge, patients'apnea status will be assessed using questionnaires.
Through these analyses, we aim to establish criteria for selecting the optimal tonsillectomy technique for pediatric OSA, and to provide evidence that will contribute to the development of clinical guidelines and the standardization of medical practice in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative pain scores (daily assessment on postoperative days 1 to 5 using the FLACC scale)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 3 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children diagnosed with obstructive sleep apnea (OSA)
Scheduled to undergo surgery with either CIT, PIT, or the conventional method
Cases in which postoperative follow-up is possible
Cases for which informed consent can be obtained from the guardian
Key exclusion criteria
Cases in which surgery is performed at another institution
Cases not undergoing adenoidectomy
Cases participating in other interventional studies during the study period
Children with severe motor and intellectual disabilities
Children considered to be at high risk of bleeding like hematologic diseases or taking antiplatelet agents
Children with concomitant conditions related to apnea, such as craniofacial malformations, pharyngeal stenosis, or mixed-type sleep apnea
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | MASAO |
| Middle name | |
| Last name | NODA |
Organization
Jichi medical university
Division name
Otolaryngology
Zip code
329-0411
Address
3311-1, Yakushiji, Shimotsuke, Tochigi
TEL
0285442111
mnoda@jichi.ac.jp
Public contact
Name of contact person
| 1st name | MASAO |
| Middle name | |
| Last name | NODA |
Organization
Jichi medical university
Division name
Otolaryngology
Zip code
329-0411
Address
3311-1, Yakushiji, Shimotsuke, Tochigi
TEL
0285442111
Homepage URL
doforanabdosuc@gmail.com
Sponsor or person
Institute
Jichi medical university
Institute
Department
Personal name
Masao Noda
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi medical univeristy
Address
3311-1, Yakushiji, Shimotsuke, Tochigi
Tel
0285442111
mnoda@jichi.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
栃木県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will be conducted as a multicenter prospective observational study, with Jichi Medical University Hospital serving as the coordinating center and responsible for data analysis
Management information
Registered date
| 2025 | Year | 10 | Month | 03 | Day |
Last modified on
| 2025 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067809
